Probe, Radiofrequency Lesion
Radiofrequency Cannula - Straight Blunt
1manufacturer
66catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | St. Jude Medical, United States |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K090955 |
| Record published | 2017-04-07 |
| Record revised | 2025-11-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in a cool and dry place; avoid exposure to extreme temperatures |
| Packaging | Pack of 10, pack of 5 |
| Sizes | Length 5 to 20 cm; needle gauge 16 to 22 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| RFDE-5 | Length 5 cm | In distribution |
| SL-C1510-18 | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL-S1010-20 | Length 10 cm | In distribution |
| SL-S1005-22 | Length 10 cm | In distribution |
| RF-SE-5 | Length 5 cm | In distribution |
| SL-S1005-20 | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RF-SE-20 | Length 20 cm | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RFDE-20 | Length 20 cm | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| SL-C1510-20 | Length 15 cm | In distribution |
| RFDE-10 | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL-S1510-20 | Length 15 cm | In distribution |
| RFDEUK-10 | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| SL-C1010-20-R | Needle Gauge 20 G | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| RF-NE-20 | Length 20 cm | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL-C1005-20 | Length 10 cm | In distribution |
| RF-SE-15 | Length 15 cm | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| RFDEUK-20 | Length 20 cm | In distribution |
| SL-S1010-22 | Length 10 cm | In distribution |
| RF-NE-10 | Length 10 cm | In distribution |
| SL-C1005-22 | Needle Gauge 22 G | In distribution |
| RF-NE-15 | Length 15 cm | In distribution |
| SL-S1505-20 | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| SL-S505-22 | Needle Gauge 22 G | In distribution |
| RF-NE-5 | Length 5 cm | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| SL-C1010-22 | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| SL-C1010-18 | Length 10 cm | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| RFDEUK-15 | Length 15 cm | In distribution |
| SL-C1010-20 | Length 10 cm | In distribution |
| SL-C505-22 | Length 5 cm | In distribution |
| CLASSIC | Length 15 cm | In distribution |
| CLASSIC | Length 5 cm | In distribution |
| RFDEUK-5 | Length 5 cm | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RFDE-15 | Length 15 cm | In distribution |
| CLASSIC | Length 10 cm | In distribution |
| RF-SE-10 | Length 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OWL | Diros Technology, Inc. | 345 |
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| Halyard | Avanos Medical, Inc. | 156 |
| Lccs | Lccs Products Limited | 101 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| NeuroTherm™ | Neurotherm, Inc. | 87 |
| cannulaRFK | Cosman Medical, Inc. | 56 |
| Rftl | Pajunk Gmbh Medizintechnologie | 54 |
| Radiofrequency (RF) Needle | Spectra Medical Devices, LLC | 49 |
| cannulaCC | Cosman Medical, Inc. | 47 |
| Epimed | Minta Medical Limited | 35 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| St. Jude Medical, Cardiology Division, Inc. | 510(k) number | 2019-11-11 | Class II | Process control | A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas. | 470 devices | 2021-04-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.